UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT FILED PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): NOVEMBER 8, 2004 ZONAGEN, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) DELAWARE 0-21198 76-0233274 (STATE OR OTHER JURISDICTION OF (COMMISSION FILE NUMBER) (I.R.S. EMPLOYER IDENTIFICATION NO.) INCORPORATION OR ORGANIZATION) 2408 TIMBERLOCH PLACE, SUITE B-1 THE WOODLANDS, TEXAS 77380 (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES AND ZIP CODE) (281) 719-3400 (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) ITEM 8.01. OTHER INFORMATION Zonagen, Inc. announced in a press release on November 8, 2004 preliminary one month findings from its study of Progenta(TM) in the treatment of uterine fibroids. The study included three dose levels of Progenta(TM) as well as placebo and positive control arms. The positive control was Lucrin(R), a GnRH agonist, commonly used for the treatment of fibroids. Progenta(TM) was administered as a daily oral dose of either 12.5mg, 25mg, or 50mg capsules. The last day of dosing for the study will occur in the second half of December 2004. Final results will be released as soon as practical thereafter. A copy of the Company's press release is attached hereto as Exhibit 99.1. The press release is incorporated by reference herein and the foregoing description of the press release is qualified in its entirety by reference to the attached exhibit. ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS c. Exhibits Exhibit Number Description ------ ----------- 99.1 Press Release dated November 8, 2004. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ZONAGEN, INC. Date: November 12, 2004. By: /s/ Louis Ploth, Jr. ------------------------------------------ Louis Ploth, Jr. Vice President, Business Development and Chief Financial Officer EXHIBIT INDEX Exhibit Number Description ------- ------------ 99.1 Press Release dated November 8, 2004.